Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System

Inclusion Criteria: * Moderate to severe or severe (≥3+) mitral regurgitation. * Age ≥ 18 years. * Patients at high risk for traditional open-heart surgery, defined as: STS mortality risk for mitral valve replacement ≥ 8%; OR presence of 2 or more frailty indices; OR presence of 2 or more major organ dysfunctions that cannot be improved post-operatively; OR other comorbidities or factors making them unsuitable for surgery. * Anatomically suitable for transcatheter MitraFix® system implantation via a transfemoral-transseptal approach as assessed by the investigator; the transfemoral-transseptal access route meets the requirements of the delivery system. * Able to understand the study purpose, voluntarily participate, sign the informed consent form, and willing to accept relevant examinations and clinical follow-ups. Exclusion Criteria: * Severe mitral stenosis. * Severe calcification of mitral leaflets and/or annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation. * High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT/TEE planning (estimated neo-LVOT \< 150 mm²), which cannot be avoided by procedural optimization. * Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.). * Infective endocarditis or evidence of active infection. * Stroke or transient ischemic attack (TIA) within 90 days. * Sever…